Quality Manager
Reporting to: Director of Scientific Operations
Primary Objective:
Provide leadership to the Quality team at Central Pharma, a company that provides manufacturing, filling and packing, specialist storage and logistics, regulatory support, serialisation, and technology services to the pharmaceutical, medical device, cell & gene, and healthcare industries.
Role Responsibilities:
- Acting as a Responsible Person import (RPi) and Responsible Person (RP)
- Lead and develop the Quality Assurance and Quality Control functions, to enable the delivery of first-class support and QA oversight across the sites to ensure that all activities are carried out in a GMP compliant manner.
- Ensure the timely and compliant release of product to customers, in accordance with the requirements of the relevant manufacturing and marketing authorisations, so as not to cause delays in supply, by ensuring sufficient QP resources are available.
- Provide management, integration, and continuous improvement of the Quality Management Systems within Central Pharma
- Assess current and developing regulations and regulatory position in order to develop and implement changes within the business to ensure continued compliance.
- Harmonise site Quality Review meetings and identify and implement corrective actions to ensure quality/regulatory requirements are met across all sites.
- To select, train, motivate and develop both team and individual performance.
Required Skills and Experience:
- Qualified to Degree level or equivalent in Science and be a member of the appropriate professional body
- Have experience in MHRA inspections.
- Have significant experience in a modern manufacturing environment within the pharmaceutical industry.
- Have a comprehensive understanding of EU regulatory guidelines and the product licensing processes, GMP/GDP requirements, Quality Management systems and the principles of risk management as defined in ICH Q9 and its practical application in a manufacturing and/or packing environment.